Description
Azole antifungals are used to treat serious fungus infections that may occur in different
parts of the body. These medicines may also be used for other problems as determined by
your doctor.

Azole antifungals are available only with your doctor's
prescription, in the following dosage forms:

Oral

Fluconazole

Capsules (Canada)

Oral suspension (U.S. and Canada)

Tablets (U.S. and Canada)

Itraconazole

Capsules (U.S. and Canada)

Oral solution (U.S.)

Ketoconazole

Oral suspension (Canada)

Tablets (U.S. and Canada)

Parenteral

Fluconazole

Injection (U.S. and Canada)

Itraconazole

Injection (U.S.)

Proper Use of This MedicineKetoconazole and the capsule form of itraconazole should be taken with a
fullmeal. The oral solution form of itraconazole should be taken on an empty
stomach. If you have any questions about the antifungal medicine you are taking, check
with your health care professional.

For patients taking the oral liquid form of fluconazole,
itraconazole, or ketoconazole:

Use a specially marked measuring spoon or other device to
measure each dose accurately. The average household teaspoon may not hold the right amount
of liquid.

If you have achlorhydria (absence of stomach acid) or
hypochlorhydria (decreased amount of stomach acid), and you are taking itraconazole or
ketoconazole, your doctor may want you to take your medicine with an acidic drink. You
may dissolve your medicine in cola or seltzer water and drink the solution, or your may
take your medicine with a glass of cola or seltzer water. Your doctor may suggest that you
dissolve each capsule or tablet in a teaspoonful of weak hydrochloric acid solution to
help you absorb the medicine better. Your health care professional can prepare the
solution for you. After you dissolve the tablet in the acid solution, add this mixture to
a small amount (1 or 2 teaspoonfuls) of water in a glass. Drink the mixture through a
plastic or glass drinking straw. Place the straw behind your teeth, as far back in your
mouth as you can. This will keep the acid from harming your teeth. Be sure to drink all
the liquid to get the full dose of medicine. Next, swish around in your mouth about
one-half glass of water and then swallow it. This will help wash away any acid that may
remain in your mouth or on your teeth.

To help clear up your infection completely, it is very
important that you keep taking this medicine for the full time of treatment , even if
your symptoms begin to clear up or you begin to feel better after a few days. Since fungus
infections may be very slow to clear up, you may have to continue taking this medicine
every day for as long as 6 months to a year or more. Some fungus infections never clear up
completely and require continuous treatment. If you stop taking this medicine too soon,
your symptoms may return.

This medicine works best when there is a constant amount in
the blood. To help keep the amount constant, do not miss any doses . Also, it is
best to take each dose at the same time every day. If you need help in planning the
best time to take your medicine, check with your health care professional.

Dosing - The dose of azole antifungals may be
different for different patients. Follow your doctor's orders or the directions on the
label. The following information includes only the average doses of azole antifungals.
Your dose of fluconazole may be different if you have kidney disease. If your dose is
different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets, or the amount of oral
suspension or injection that you take depends on the strength of the medicine. Also, the
number of doses you take each day, the time allowed between doses, and the length of time
you take the medicine depend on the medical problem for which you are taking azole
antifungals.

For fluconazole

For fungus infections:

For capsule dosage form:

Adults150 milligrams (mg) as a single dose to treat vaginal
yeast infections.

Children up to 18 years of ageDose must be determined by
your doctor.

For oral suspension and tablet dosage forms:

Adults and teenagers200 to 400 mg on the first day, then 100
to 400 mg once a day for weeks or months, depending on the medical problem being treated.
A vaginal yeast infection is treated with a single dose of 150 mg.

Children 6 months of age and older6 to 12 mg per kilogram
(mg/kg) (2.7 to 5.4 mg per pound) of body weight on the first day, then 3 to 12 mg/kg
(1.35 to 5.4 mg per pound) of body weight once a day for weeks or months, depending on the
medical problem being treated.

Infants and children up to 6 months of ageDose must be
determined by your doctor.

For injection dosage form:

Adults and teenagers200 to 400 mg on the first day, then 100
to 400 mg once a day, injected into a vein, for weeks or months, depending on the medical
problem being treated.

Children 6 months of age and older6 to 12 mg per kilogram
(mg/kg) (2.7 to 5.4 mg per pound) of body weight on the first day, then 3 to 12 mg/kg
(1.35 to 5.4 mg per pound) of body weight once a day, injected into a vein, for weeks or
months, depending on the medical problem being treated.

Infants and children up to 6 months of ageDose must be
determined by your doctor.

For itraconazole

For fungus infections:

For capsule dosage form:

Adults and teenagers200 milligrams (mg) once a day, which
may be increased up to 400 mg once a day for weeks or months, depending on the medical
problem being treated. Fingernail and toenail infections are treated with 200 mg one or
two times a day for weeks or months.

Children up to 16 years of ageDose must be determined by
your doctor.

For injection dosage form:

Adults200 milligrams (mg) twice a day for 4 doses, then 200
mg once a day.

ChildrenDose must be determined by your doctor.

For oral solution dosage form:

Adults and teenagers100 to 200 mg once a day for days or
weeks, depending on the medical problem being treated.

Children up to 12 years of ageDose must be determined by
your doctor.

For ketoconazole

For fungus infections:

For oral dosage form (oral suspension and tablets):

Adults and teenagers200 to 400 milligrams (mg) once a day
for days or weeks, depending on the medical problem being treated.

Children over 2 years of age3.3 to 6.6 mg per kilogram (1.5
to 3 mg per pound) of body weight once a day for days or weeks, depending on the medical
problem being treated.

Infants and children up to 2 years of ageDose must be
determined by your doctor.

Missed dose - If you miss a dose of this medicine,
take it as soon as possible. This will help to keep a constant amount of medicine in the
blood. However, if it is almost time for your next dose, skip the missed dose and go back
to your regular dosing schedule. Do not double doses.

Storage - To store this medicine:

Keep out of the reach of children.

Store away from heat and direct light.

Do not store the capsule or tablet form of this medicine in
the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause
the medicine to break down.

Keep the oral liquid form of this medicine from freezing.

Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of children.

Additional Information
Once a medicine has been approved for marketing for a certain use, experience may show
that it is also useful for other medical problems. Although these uses are not included in
product labeling, azole antifungals are used in certain patients with the following
medical conditions:

Cryptococcosis

Cushing's syndrome

Febrile neutropenia

Fungus infections in newborns

Hirsutism

Histoplasmosis

Paronychia (infection of the tissue surrounding the nail)

Penicillium marneffei infection

Pneumonia caused by fungus

Prostate cancer

Ringworm of the beard, hand, or scalp

Septicemia (infection of the blood) caused by fungus

Skin infection (including leishmaniasis and sporotrichosis)

Other than the above information, there is no additional
information relating to proper use, precautions, or side effects for these uses.

Before Using This Medicine
In deciding to use a medicine, the risks of taking the medicine must be weighed against
the good it will do. This is a decision you and your doctor will make. For the azole
antifungals, the following should be considered:

Allergies - Tell your doctor if you have ever had
any unusual or allergic reaction to any of the azole antifungals. Also tell your health
care professional if you are allergic to any other substances, such as foods,
preservatives, or dyes.

Pregnancy - Studies have not been done in pregnant
women. However, studies in some animals have shown that azole antifungals, taken in high
doses, may cause harm to the mother and the fetus. They have caused birth defects in
animals. Before taking these medicines, make sure your doctor knows if you are pregnant or
if you may become pregnant.

Breast-feeding - Azole antifungals pass into breast
milk. Mothers who are taking these medicines and who wish to breast-feed should discuss
this with their doctors.

Children - A small number of children have been
safely treated with azole antifungals. Be sure to discuss with your child's doctor the use
of these medicines in children.

Older adults - Many medicines have not been studied
specifically in older people. Therefore, it may not be known whether they work exactly the
same way they do in younger adults or if they cause different side effects or problems in
older people. There is no specific information comparing use of azole antifungals in the
elderly with use in other age groups.

Other medicines - Although certain medicines should
not be used together at all, in other cases two different medicines may be used together
even if an interaction might occur. In these cases, your doctor may want to change the
dose, or other precautions may be necessary. When you are taking azole antifungals, it is
especially important that your health care professional know if you are taking any of the
following:

Terfenadine (e.g., Seldane)These medicines should not be
taken with fluconazole, itraconazole, or ketoconazole; these azole antifungals may
increase the chance of serious side effects of astemizole or terfenadine

Atorvastatin (e.g., Lipitor ® (marchio registrato) or

Cerivastatin (e.g., Baycol) or

Lovastatin (e.g., Mevacor) or

Simvastatin (e.g., Zocor)Use of these drugs with
itraconazole or ketoconazole since increased levels of these drugs can cause serious
muscular disorders.

Busulfan (e.g., Myleran) or

Docetaxel (e.g., Taxotere) or

Vinblastine (e.g., Velban) or

Vincristine (e.g., Oncovin)Metabolism of these drugs may be
delayed by itraconazole.

Felodipine (e.g., Plendil) or

Nifedipine (e.g., Procardia) or

Verapamil (e.g., Isoptin, Covera)Concurrent use can cause
water retention or slow the heart rate.

Carbamazepine (e.g., Tegretol) or

Phenobarbital (e.g., Luminal)

Phenytoin (e.g., Dilantin)Concurrent use with itraconazole
may decrease itraconazole concentrations. Phenytoin concentrations may be increased.

Cisapride (e.g., Propulsid)Cisapride should not be taken
with itraconazole or oral ketoconazole; these azole antifungals may increase the chance of
serious side effects of cisapride

Cyclosporine (e.g., Sandimmune, Neoral)

Tacrolimus (e.g., Prograf)Concomitant use may cause
increased concentrations of these drugs, resulting in toxicity.

Didanosine (e.g., ddI, Videx)Use of didanosine with
itraconazole or ketoconazole may decrease the effects of itraconazole or ketoconazole, as
well as of didanosine. Itraconazole and ketoconazole should be taken at least 2 hours
before or 2 hours after didanosine is given

Digoxin (e.g., Lanoxin)Digoxin concentrations may be
increased, resulting in toxicity.

Dofetilide (eg., Tikosyn) or

Pimozide (e.g.,Orap) or

Quinidine (e.g., Quinaglute, Cardioquin, Quinidex) Pimozide,
dofetilide and quinidine should not be taken with itraconazole; itraconazole may increase
the chance of serious side effects of pimozide, dofetilide and quinidine.

Indinavir (e.g., Crixivan) or

Ritonavir (e.g., Norvir) or

Saquinivir (e.g., Invirase)Use of these drugs with
itraconazole or ketoconazole may increase the effects of indinavir

Erythromycin (e.g., E-Mycin)Plasma concentrations of
itraconazole may be increased.

Nevirapine (e.g., Viramune)Plasma concentrations of
itraconazole or ketoconazole may be decreased.

Warfarin (e.g., Coumadin)Anticoagulant effects may be
increased.

Other medical problems - The presence of other
medical problems may affect the use of azole antifungals. Make sure you tell your doctor
if you have any other medical problems, especially:

Congestive heart failureItraconazole may slow down the heart
rhythm and make heart failure worse.

Achlorhydria (absence of stomach acid) or

Hypochlorhydria (decreased amount of stomach
acid)Itraconazole and ketoconazole may not be absorbed from the stomach as well in
patients who have low levels of or no stomach acid

Alcohol abuse (or history of) or

Liver diseaseAlcohol abuse or liver disease may increase the
chance of side effects caused by azole antifungals

Kidney diseaseThe effects of fluconazole may be increased in
patients with kidney disease

Precautions While Using This Medicine
It is important that your doctor check your progress at regular visits. This will allow
your doctor to check for any unwanted effects.

If your symptoms do not improve within a few weeks (or
months for some infections), or if they become worse, check with your doctor.

These medicines should not be taken with
astemizole (e.g., Hismanal), cisapride (e.g., Propulsid),dofetilide (e.g., Tikosyn) or
terfenadine (e.g., Seldane). Doing so may increase the risk of serious side effects
affecting the heart.

Liver problems may be more likely to occur if you drink
alcoholic beverages while you are taking ketoconazole. Alcoholic beverages may also cause
stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other
alcohol-containing preparations (for example, elixirs, cough syrups, tonics) may also
cause problems. These problems may occur for at least a day after you stop taking
ketoconazole. Therefore, you should not drink alcoholic beverages or use
alcohol-containing preparations while you are taking this medicine and for at least a day
after you stop taking it.

If you are taking antacids, cimetidine (e.g., Tagamet),
famotidine (e.g., Pepcid), nizatidine (e.g., Axid), omeprazole (e.g., Prilosec), or
ranitidine (e.g., Zantac) while you are taking itraconazole or ketoconazole, take the
other medicine at least 2 hours after you take itraconazole or ketoconazole . If you
take these medicines at the same time that you take itraconazole or ketoconazole, they
will keep your antifungal medicine from working properly.

Ketoconazole may cause your eyes to become more sensitive
to light than they are normally. Wearing sunglasses and avoiding too much exposure to
bright light may help lessen the discomfort.

Along with its needed effects, a medicine may cause some
unwanted effects. Although not all of these effects may occur, if they do occur they may
need medical attention.

Check with your doctor immediately if any of the
following side effects occur:

Other side effects may occur that usually do not need
medical attention. These side effects may go away during treatment as your body adjusts to
the medicine. However, check with your doctor if any of the following side effects
continue or are bothersome: